Daruvir®(Darunavir)

Daruvir® is indicated to treat HIV-1 (Human Immunodeficiency Virus type 1) infection in treatment-experienced and treatment-naive patients. Daruvir® is used alongside Ritonavir and is suitable for adults and pediatric patients of 3 years of age and older with weight at least 15 kg. Be aware, Daruvir® is not a cure for HIV infection.
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Description

Daruvir® is manufactured by Cipla. The raw material is Darunavir – is a protease inhibitor used to treat HIV. It acts on the HIV aspartyl protease which the virus needs to cleave the HIV polyprotein into its functional fragments.

Indications:

MOA (mechanism of action):

Darunavir is a HIV protease inhibitor which prevents virus replication by binding to the enzyme's active site. This averts the dimerization and the catalytic activity of the HIV-1 protease. Darunavir selectively inhibits the cleavage of HIV encoded Gag-Pol polyproteins in viral cells, which prevents the formation of mature infectious virus fragments. Darunavir is active against HIV-2.

For treatment-naive children of 3 years of age and older (weight at least 15 kg):

15–30 kg: 600 mg with Ritonavir 100 mg once daily.

30–40 kg: 675 mg with Ritonavir 100 mg once daily.

40 kg and more: 800 mg with Ritonavir 100 mg once daily.

For treatment-experienced children of 3 years of age and older (weight at least 15 kg):

15–30 kg: 600 mg with Ritonavir 100 mg once daily.

30–40 kg: 675 mg with Ritonavir 100 mg once daily.

40 kg and more: 800 mg with Ritonavir 100 mg once daily.

Directions for use:

Take Daruvir® always together with Ritonavir. Daruvir® cannot work properly without Ritonavir.

Take Daruvir® with food. Daruvir® cannot work properly without food. The type of food is not important.

Swallow the tablets with a drink such as water or milk.

Precautions:

HIV can be transmitted through sexual contact with HIV positive partner, blood (e.g., sharing needles, handling blood instruments, receiving blood transfusions, blood products, or organ/tissue transplants that were infected with HIV), childbirth, toiletries (razors and toothbrushes).Therefore, both HIV-positive and HIV-negative individuals are advised to have any kind of sex using a latex or polyurethane condom, avoid sharing needles or other things like toothbrushes or razors. It is important to discuss with doctor the precautions needed to avoid infecting other people as well as take precautions not to get infected.

Women who are HIV-positive must not breastfeed because HIV infection can be passed on to the baby in breast milk.

Some people who take Daruvir® may experience:

- Liver problems, which may be life-threatening. Tell your healthcare provider immediately if you have any symptoms: dark (tea-colored) urine, yellowing of your skin or whites of your eyes, pale-colored stools, nausea, vomiting, pain or tenderness on your right side below your ribs, loss of appetite, or fatigue.

- Skin rash, which may become severe or potentially life-threatening. Please seek medical advice immediately if you develop a rash.

- Immune reactivation syndrome (severe immune deficiency during combination anti-retroviral therapy (CART) may lead to arousal of opportunistic infections and cause serious clinical conditions), autoimmune disorders. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness in hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please seek medical advice immediately.

- Osteonecrosis (the death of bone tissue). Patients should seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.

Missing a dose

If you notice within 6 hours, you must take your missed dose immediately. Always take with Ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Overdose

If an overdose occurs and you are not feeling well, stop taking the medication immediately. You should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store Daruvir® tablets or oral powder at room temperature between 68-77 degrees F (20-25 degrees C). Keep out of the reach of children. Do not throw away any medications via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use.

Frequently asked questions

Q: What is Daruvir® used for?

A: Daruvir® is indicated to treat HIV-1 (Human Immunodeficiency Virus type 1) infection in treatment-experienced and treatment-naive patients. Daruvir® is used alongside Ritonavir and is suitable for adults and pediatric patients of 3 years of age and older with weight at least 15 kg. Be aware, Daruvir® is not a cure for HIV infection.

Q: How should I take Daruvir®?

A: Take Daruvir® always together with Ritonavir. Daruvir® cannot work properly without Ritonavir. Take Daruvir® with food. Daruvir® cannot work properly without food. The type of food is not important. Swallow the tablets with a drink such as water or milk.

Q: Can I breastfeed if I take Daruvir®?

A: Women who are HIV-positive must not breastfeed because HIV infection can be passed on to the baby in breast milk.

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